EMA launches EU Clinical Trials Register

An online register giving the public access to information on clinical trials authorised in the 27 EU Member States as well as Iceland, Liechtenstein and Norway has been launched by the European Medicines Agency (EMA).

The EU Clinical Trials Register, which draws on information from EudraCT, the EU’s clinical trials database, also permits searches on trials approved outside the European Union where these are part of an EU paediatric investigation plan.

It does not yet include summaries of clinical trial results, whose publication will require “a major upgrade to the existing system”, the EMA says.

The register at https://www.clinicaltrialsregister.eu is part of EudraPharm, the overarching EU public database that provides a centralised source of information on medicines authorised in the European Union, such as details of patient information leaflets.

The EMA is responsible for the day-to-day management of the new register, which incorporates information provided by the sponsor on approved interventional clinical studies of medicines as part of its application to a national regulatory authority to conduct the trial.

The national authority loads this information into the EudraCT database and supplements it with the clinical trial approval and relevant ethics committee opinion. Information on third-country trials listed in a paediatric investigation plan (PIP) is supplied directly to the system, via the EMA, by the party to that programme.

Trials on the register include those conducted by industry and research institutes alike, with the information made public once a clinical study has been authorised. The scope of the Register is information from any paediatric clinical trial and any Phase II-IV adult clinical trial recorded on EudraCT.

The paediatric trials are those with investigator sites in the European Economic Area (EEA) and those forming part of a PIP where the investigator sites are all outside the EEA. The adult trials are those with investigator sites in the EEA or listed in a PIP.

Delayed launch

As the EMA acknowledged, the EU Clinical Trials Register was originally scheduled to be launched at the end of 2009.

When EudraCT was set up in May 2004, it was as a confidential database. This confidentiality was partially lifted by EU regulations in 2004 and 2006 respectively. However, the regulations needed implementing guidance, which was subsequently published by the European Commission in July 2008 and February 2009 respectively.

The EMA put the further delays in launching the Register down to “the challenges of converting the database to its current structure to support this and future developments”, as well as “additional difficulties encountered in data migration and testing” of the relevant software.

According to the European Commission, having an official register open to the public should make clinical research more transparent for patients, healthcare professionals, the research community and others, while avoiding unnecessary duplication.

Every year some 4,000 clinical trials are approved in the EU. Since most of them last two to three years, it means around 10,000 trials are ongoing at any given time, the Commission pointed out.

Results summaries

The EMA said it would continue to work with stakeholders to improve the functioning of the EU Clinical Trials Register, in particular by enhancing the quality and completeness of the data, and by improving the search functionality.

There are plans to publish in future summaries of clinical trial results, which have been a feature of ClinicalTrials.gov, the public online registry run by the US National Institutes of Health, since October 2008.

As the EMA noted, though, at the moment summaries of trial results are not included on EudraCT and will have to await the launch of Version 9.0 of the EU’s clinical trials database. The aim is to introduce the summary results feature in late 2012, based on guideline to be published by the European Commission.

A draft version of that document, under the title, Implementing technical guidance - List of fields for result-related information to be submitted to the ‘EudraCT’ clinical trials database, and to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 and Article 41 of Regulation (EC) No 1901/2006 and their implementing guidelines 2008/C168/02 and 2009/C28/01, was out for consultation from May to September 2010.

The EMA said publication of results summaries on the EU Register of Clinical Trials would “require a major upgrade to the existing system, the start of which will depend on finalisation of the [draft] guideline and availability of budget and resources”.